Medical device manufacturers face many of the same challenges that other producers of complex devices and equipment face: controlling costs, maintaining tight inventories and well-coordinated global supply chains, and sustaining flexibility in their production operations so they can change product mix and introduce new products as market requirements change and new opportunities arise.
However, medical device manufacturers also face several challenges unique to their industry:
- They produce vital, life-saving products that millions of people depend on for both short-term and long-term care.
- Their work and products are highly regulated, with concurrent requirements for extensive documentation and rigorous quality control of their operations.
- Cost pressures due to both government price controls in many markets and competition lead some manufacturers to locate production in low-cost countries or to invest in increased automation to manage labor costs.
Whether a company is producing diagnostic equipment for cancer screening, ventilators for ICUs, disposable devices such as syringes, or implantable devices such as pacemakers or stents for cardiac procedures, the manufacturing process must be error-free. At the same time, to be profitable and agile, there is a constant need to sustain high levels of throughput and the ability to “flex” their production systems to remain competitive and satisfy emerging market needs.
At first glance, faster throughput and virtually error-free manufacturing would seem to be two competing goals. To achieve them, companies are investing more and more in the latest factory automation systems and tools—the technology of the Factory of the Future.
Defining the Factory of the Future
The Factory of The Future is an intelligent, flexible, and highly agile production environment that equips plant operations and management with the real-time, in-depth information they need to maximize the value and performance of every machine and production unit.
Everything is connected in the Factory of the Future, also referred to as Industry 4.0 or i4.0. Networks connect the individual machine components with embedded sensors and intelligence up through machine-level and plant-level communications architectures to a cloud-based solution. Sophisticated software collects, transfers, and processes data in ways to provide both production transparency and actionable answers to questions about production bottlenecks, inefficient workflows, and equipment in need of preventive maintenance.
The potential benefits of applying this kind of technology to the challenges medical manufacturers face can be significant if the technology is used in an organized and intelligent way. Too often, manufacturers will be convinced that simply increasing the use of automated manufacturing systems and putting them on a factory-wide network will automatically result in improved productivity and greater control of manufacturing processes.
In order to make certain that Factory of the Future technology delivers maximum value, medical manufacturers need to assess several factors about their current production systems and manufacturing processes:
- Existing level of automation. How automated are your production processes—and is the automation in the right place? Depending on the product being manufactured, there are many types of assembly processes that are just as efficient and cost-effective using manual assembly systems; these workstations can be augmented with a variety of i4.0 operator-assist technologies and can be connected with smart-powered conveyor systems.
- Upgrading legacy production systems. Many manufacturing plants contain a mix of machines, from legacy equipment with little or no intelligent controls, sensors, or communications capabilities to state-of-the-art systems fully equipped for Factory of the Future operation. Assessing the status of older systems and developing incremental, step-by-step strategies to upgrade them is crucial to getting the best return on i4.0 investments.
- The status of lean. All the Factory of the Future technology in the world can’t correct fundamental problems of waste and poorly organized workflows. i4.0 technology can only be effectively implemented and generate the best returns when manufacturers have well-established lean culture and practices present.
- Globalization. Some medical device manufacturers are expanding global supply and manufacturing chains but keeping the highest levels of quality between existing high-cost manufacturing locations and newer, lower-cost sites, which may combine automation and manual assembly and could lead to potential problems. i4.0 technology can provide solutions including real-time, cloud-based production data sharing and analysis.
Above: Workstations can be augmented with a variety of i4.0 operator-assist technologies and can be connected with smart-powered conveyor systems.
Strategies for Applying i4.0 Technology
Once medical device manufacturers have assessed their operations and production systems, it’s important to develop strategies for acquiring and implementing i4.0 technology, targeting four key industry areas that offer significant opportunities for improvements:
- Complex product mix
- Throughput requirements
- Quality standards and control
- Regulatory response
In medical device manufacturing, i4.0 technology can help solve the interrelated challenges of complex product mix and increasing productivity and throughput. Whether the products are pacemakers, cochlear implants, or portable oxygen concentrators, many medical devices are complex products made up of a wide range of components.
For these and other kinds of complex products, manufacturing processes must supply high throughput rates while being assembled and are tested according to very tight quality control processes—especially products that need to be safely and permanently implanted.
Many companies have widely changing product mixes and need the flexibility to make production changeovers as quickly and efficiently as possible. Depending on the device being fabricated or assembled, the production system can be highly automated or be a mix of manual assembly and automated production.
Factory of the Future technologies can address these challenges in several ways. Increased use of sensors installed in key points of automated assembly and packaging machines, as well as at workstations and transport systems, can provide new data that pinpoints where problems are occurring, such as bottlenecks, unscheduled disruptions, or equipment that needs servicing—in many ways, before the problems become acute.
Many simple devices, like pneumatic control valves or linear motion components, now integrate sensors into their designs and can supply useful performance data from multiple points in a production line. Many more advanced components, such as electric motor drives and PLCs, are sophisticated enough to function as edge devices, processing performance data to make it more easily used in real time by production managers.
Above: IoT (Internet of Things) “gateways” — edge-computing devices that collect the data from across the factory floor.
However, data from one production line or machine may not be sufficient to address broader productivity and throughput challenges. To maximize insight, manufacturers should consider implementing new tools like IoT (Internet of Things) “gateways”—edge-computing devices that collect the data from across the factory floor. These gateways normalize the data streams to provide a coherent and actionable portrait of production in real time.
The data can be centralized at the plant level with the local dashboard, and you could eventually scale up to using the gateway, connecting all production locations through the cloud and utilizing cloud-based analytics that roll that data up and present it for agile, real-time assessment of ways to improve throughput and manage product changeovers.
This kind of technology—the expanded use of sensors, edge devices, and IoT gateways—can also provide a powerful Factory of the Future platform to help enhance how medical device manufacturers comply with regulatory oversight and documentation requirements.
Depending on the devices being manufactured, regulators may require documentation of machine parameters—and deviations—on a part-by-part produced basis. While many automated assembly and packaging systems now incorporate that kind of tracking, to make the data useful to production management—not just capturing it for documentation purposes—edge systems like IoT gateway can improve and simplify how that data is collected, collated, and reported to plant-level operations.
This kind of Factory of the Future technology can elevate the consistency and accuracy of manufacturing processes across the enterprise, especially if the company has multiple generations of machines. It can also provide vital real-time data to help companies apply lean principles and processes, by uncovering previously unknown wasted time or efforts related to the timely flow of materials to workstations and through production lines.
Factory of the Future technologies can also provide a powerful tool for device manufacturers globalizing their supply chains and production operations. There can be a risk associated with moving some production operations to lower-cost countries if quality controls and assembly processes are not sufficiently established and standardized.
There is a range of useful workstation and factory floor technologies that are both technologically advanced yet relatively low in cost. Delivery of workpieces and components to workcells can be efficiently automated with flexible conveyor systems that utilize bar code readers or RFID tags to keep an intelligent flow of materials to workstations just as they are needed, oriented in the right direction for maximum ergonomic efficiency.
Interactive digital assembly guides and vision systems at the manual workstation can reduce errors, with worker-assist systems programmed to present information in the worker’s language of choice and automatically reconfigure to match the part being built.
In addition, these tools can minimize downtime and wasted effort by reducing the amount of training or supervisor support/oversight with new personnel. Smart assembly assist systems can help ensure that the right part is pulled from the right bin, preventing wasted time and motion as well as reducing the potential for assembled devices to be diverted for rework.
To augment the efficiency and improve the application of lean processes in these kinds of i4.0-enabled assembly operations, a new generation of digital Kanban boards are now being made available. These systems display aggregated production data in real-time, using easy-to-understand graphs and visualization, to help individual workers and work teams better understand how their entire production line or plant is doing.
Standardizing on these kinds of production tools in every manufacturing location, then using IoT gateways to capture and process that data from across a company’s global locations, is a powerful way to mitigate the risks and enhance the productivity and value of global medical device manufacturing.
Above: A new generation of digital Kanban boards are now being made available that display aggregated production data in real-time.
Finding the Right Factory of the Future Solutions
Many companies and suppliers claim to have Industry 4.0 technology ready to be installed into medical device manufacturing operations. However, good technology is not enough—deep insight into the right way to apply Factory of the Future technology is equally important.
One way to ensure success is to work with knowledgeable suppliers whose technology is fully aligned with Factory of the Future concepts. This includes having a deep understanding of lean processes and principles and an understanding of how to use technology within a lean operation to maximize the outcomes of continuous improvement processes.
The right supplier will have a broad portfolio of Factory of the Future technologies that include products for automation and manual assembly. By working with these kinds of suppliers, you can incrementally plan and implement the right mix of Factory of the Future technologies to satisfy the goals you have set to improve quality control, regulatory compliance and productivity across your enterprise.